UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029470 |
|---|---|
| Receipt number | R000033646 |
| Scientific Title | Submucosal Fibrosis Prediction in Colorectal Tumor undergoing ESD |
| Date of disclosure of the study information | 2017/11/30 |
| Last modified on | 2017/10/08 13:18:36 |
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Basic information
Public title
Submucosal Fibrosis Prediction in Colorectal Tumor undergoing ESD
Acronym
Fibrosis in colorectal ESD
Scientific Title
Submucosal Fibrosis Prediction in Colorectal Tumor undergoing ESD
Scientific Title:Acronym
Fibrosis in colorectal ESD
Region
| Japan |
Condition
Condition
Endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the predictive factors for presence of severe submucosal fibrosis(F2) in colorectal tumor undergoing ESD
Basic objectives2
Others
Basic objectives -Others
To evaluate clinical outcome of ESD in patients with severe fibrosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Predictive factors for presence of severe submucosal fibrosis(F2) in colorectal tumor undergoing ESD
Key secondary outcomes
Clinical outcome of ESD in patients with severe fibrosis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing colorectal ESD following the indication proposed by JGES
Key exclusion criteria
1. Patients who have recurrent colorectal tumor on prior EMR or ESD site
2. Patients with tumors associated with chronic intestinal inflammation conditions, including ulcerative colitis
3. Patients with hyperplastic polyps, inflammatory polyps and neuroendocrine tumors
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uayporn Kaosombatwattana |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550
TEL
0527442172
koigi214@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Uayporn Kaosombatwattana |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550
TEL
0527442172
Homepage URL
koigi214@gmail.com
Sponsor or person
Institute
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Nagoya University Hospital (Aichi)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective chart review
Management information
Registered date
| 2017 | Year | 10 | Month | 08 | Day |
Last modified on
| 2017 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033646
